California Stem Cell and Stemina Biomarker Discovery Announce Collaboration to Validate Effectiveness of Human Embryonic Stem Cell-Derived Cardiomyocyte Progenitors for Use in Predictive Toxicology – CardioPlate™ 96-well assay-ready plates enable predictive toxicology and high throughput screening assays

IRVINE, Calif.–Collaboration between California Stem Cell, Inc. (CSC) and Stemina Biomarker Discovery on a study using CSC’s 96-well CardioPlateTM containing high purity human embryonic stem cell (hESC)-derived cardiomyocyte progenitor cells, has demonstrated that it can be used as a model system for investigating and predicting drug induced cardiotoxicity, officials from the firms announced today.

Stemina is a Madison, Wisconsin-based metabolomics company focused on the discovery, development and commercialization of molecular biomarkers to improve drug safety and human health. The firm’s cell-based assays study the response of hESCs and hESC-derived cells, such as heart cells and neurons, to drugs or disease conditions.

“Stemina’s expertise in the area of metabolomic analysis is unparalleled, making it an ideal partner for this study,” said Dr Chris Airriess, chief operating officer of CSC. “We are very excited about the possibilities for rapid, multivariate compound screening that this technology will enable.”

The impetus behind the CSC and Stemina collaboration was to develop a predictive assay to screen for cardiotoxicity, using a variety of anti-cancer drugs with different and distinct mechanisms of action on human cardiac tissue that are known to induce cardiotoxicity and potentially cardiomyopathy, Airriess said.

CSC 96-well CardioPlatesTM, containing cardiomyocyte progenitor cells, were exposed to clinically relevant doses of anti-cancer drugs and then assayed to determine viability and cytotoxicity. “The resulting cytotoxic profiles suggest that CSC’s cardiomyocyte progenitor cells closely mimic those of the human heart, making this plate-based system an ideal in vitro model of cardiotoxic effects in vivo,” said Gabriela Cezar, Stemina’s chief scientific officer.

This cardiotoxicity screen will stand apart because of its focus on biomarkers of cardiomyopathy, a specific type of cardiotoxicity that is a common side effect of some chemotherapies, Cezar said. Once the project is complete, drug companies will be able to assess the risk that a particular drug candidate will induce cardiomyopathies during treatment. Stemina is planning in vivo studies of the biomarkers discovered through this collaboration, enrolling patients already being treated with cancer drugs. Cardiotoxicity studies using CSC’s CardioPlateTM and Stemina’s metabolomics platform are ongoing.

About Stemina Biomarker Discovery:

Stemina Biomarker Discovery is a metabolomics company focused on the discovery, development and commercialization of molecular biomarkers to improve drug safety and human health. Stemina’s cell-based assays arise from the strategic convergence of two cutting edge technologies: human embryonic stem (hES) cells and metabolomics. Stemina uses mass spectrometry to analyze the small molecules secreted by hES cells, and differentiated cells such as heart and neural cells made from hES cells, in response to drugs, injury or disease. Stemina opened its state-of-the-art facilities for hES cell culture and mass spectrometry in the UW Research Park in Madison, Wisconsin on November 1, 2007.

About California Stem Cell, Inc:

California Stem Cell, Inc is a privately held company focused on the manufacturing of high-purity human cells for therapeutic development and clinical application. Since its founding in 2005, CSC has developed and has intellectual property surrounding methods for scalable production of human motor neurons, neuronal progenitors, cardiac muscle and sino-atrial node cells at its Irvine, California facility. CSC is currently in the pre-clinical development stage of stem cell-derived therapies for spinal muscular atrophy (SMA), ALS and spinal cord injury.

CSC will be an invited presenter at the 11th Annual SoCalBio Investor and Partnership Conference at Loews Santa Monica Beach Hotel on September 17, 2009.